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Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia

NCT01648218 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-12-09

No results posted yet for this study

Summary

No consensus guidelines exist for management of post-transplant glucocorticoid induced hyperglycemia, but most published reviews recommend insulin as first line therapy. A variety of insulin regimens have been proposed, including mealtime short-acting regular or analog insulin, once daily neutral protamine hagedorn (NPH) insulin, pre-mixed insulin, or basal insulin alone such as glargine or detemir. However, no randomized trial has ever examined different insulin regimens to determine which most effectively controls post-transplant steroid-induced hyperglycemia. Consequently, the proposed study intends to examine three commonly used insulin regimens used for managing post-transplant once-daily glucocorticoid-induced hyperglycemia to determine which is most effective:

* Group 1: Intermediate-acting (NPH) insulin at breakfast
* Group 2: Short-acting insulin (regular or aspart) before meals
* Group 3: Insulin glargine at breakfast

Question/Hypothesis:

Among three commonly used insulin regimens, which is most effective for managing post-transplant once-daily glucocorticoid-induced hyperglycemia?

Conditions

  • Post-Transplant Glucocorticoid Induced Diabetes

Interventions

DRUG

Neutral protamine hagedorn (NPH) insulin

DRUG

Regular human insulin or Insulin Aspart

DRUG

Insulin glargine

Sponsors & Collaborators

  • Vancouver General Hospital

    lead OTHER

Principal Investigators

  • Breay W Paty, MD, FRCPC · Vancouver General Hospital, University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-04-30
Completion
2013-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01648218 on ClinicalTrials.gov